Manager, Medical Device Quality Systems

🕒 March 18

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Cognixion

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 2014

🤖 Artificial Intelligence

🥽 AR/VR

🔧 Hardware

Artificial Intelligence • AR/VR • Hardware

Cognixion is a neurotechnology company developing non-invasive, AI-powered brain-computer interface (BCI) hardware and assisted-reality software to enable communication, control, and clinical applications for people with complex disabilities. The company builds wearable platforms (Axon-R, Cognixion ONE) that combine neural sensing, eye-tracking, head-pose inputs, and AI to support assistive communication, clinical research, and smart-environment control, while partnering with health systems and researchers to advance accessibility and patient care.

📋 Description

• Host external audits and serves as the primary QMS representative, demonstrating compliance with ISO 13485 and applicable country-specific medical device requirements to regulators, notified bodies and other auditing organizations. • Plan and conducts internal audits to evaluate QMS conformity and effectiveness against ISO 13485 and other applicable regulatory requirements, and to verify implementation across functions. • Lead audit response activities, including root cause investigations, corrective action planning, and effectiveness verification, in collaboration with process owners and cross-functional subject matter experts. • Maintains working expertise in current and emerging medical device regulations, standards, and guidance documents relevant to Cognixion’s products and markets. • Performs regulatory and QMS compliance assessments to inform critical business decisions (e.g. product changes, market expansion, supplier strategy, system/tooling adoption). • Analyzes and trends QMS performance metrics and prepares/communicates inputs to Top Management for management review, including risks, opportunities and recommended actions. • Program-manage cross-functional initiatives to strengthen, scale and continually improve the QMS, including harmonization/globalization efforts and process optimization. • Creates, co-creates and guides implementation of QMS processes, procedures, and records to ensure consistent, audit-ready execution across the organization.

🎯 Requirements

• Bachelor’s degree, preferably in engineering, physical science, life science, or pharmacy. • Minimum of 8 years relevant industry experience in a regulated environment. • ISO 13485 Lead Auditor certification by professional body is required. • Preferred credentials: CMQ-OE, Six Sigma Black Belt Certification, PMP. • Regulatory inspection experience preferably with direct agency inspector interaction. • Strong project management skills. • Demonstrated understanding of quality assurance, quality control, regulatory, manufacturing, and principles of validation in regulated environments.